| CTRI Number |
CTRI/2025/08/092960 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the oral effect of jyotishmati vati in patient of Artavkshaya |
|
Scientific Title of Study
|
A Randomized Open Labelled Controlled Clinical Trial To Assess An Effect Of Durva Swarasa Bhavit Jyotishmati Vati In Artavkshaya With Special Reference To Oligomenorrhea |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shrikant Atmaram Dighe |
| Designation |
Ph. D Scholar |
| Affiliation |
R.A Podar Ayurved College |
| Address |
R.A Podar Ayurved College, Ground floor OPD number-8 Prasuti Tantra even Striroga department,Dr Annie Besant Road Worli Mumbai
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9970664247 |
| Fax |
|
| Email |
digheshriikant@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhagyashri Mahavir Khot |
| Designation |
Professar |
| Affiliation |
R.A Podar Ayurved College |
| Address |
R.A Podar Ayurved College, Dr Annie Besant Road Worli Mumbai
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9850539489 |
| Fax |
|
| Email |
khotbhagyashri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhagyashri Mahavir Khot |
| Designation |
Professar |
| Affiliation |
R.A Podar Ayurved College |
| Address |
R.A Podar Ayurved College, Dr Annie Besant Road Worli Mumbai
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9850539489 |
| Fax |
|
| Email |
khotbhagyashri@gmail.com |
|
|
Source of Monetary or Material Support
|
| R.A Podar Ayurved college and hospital ,Dr Annie Besant Road Worli Mumbai-400018 |
|
|
Primary Sponsor
|
| Name |
Dr Shrikant Atmaram Dighe |
| Address |
R.A Podar Ayurved College and hospital Dr Annie Besant Road Worli Mumbai-400018 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shrikant Atmaram Dighe |
R.A Podar Ayurved college and hospital |
R.A Podar Ayurved college and hospital ,Dr Annie Besant Road Worli Mumbai-400018
Mumbai
MAHARASHTRA |
9970664247
digheshriikant@gamil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee RA Podar medical college Worli Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N915||Oligomenorrhea, unspecified. Ayurveda Condition: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Jyotishmati vati, Reference: Bhaishajya Ratnavali , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Rajapravartini vati, Reference: Bhaishajya Ratnavali , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Selection irrespective of marital status, parity, socioeconomic status
Patients with sign and symptoms of Oligomenorrhea
Quantity of bleeding less than 80 mL
Hb should be greater than 8 gm%
BMI should be between 19 to 30 |
|
| ExclusionCriteria |
| Details |
Known patients of blood dyscrasias.
Known patients of major systemic diseases that are likely to influence menstrual rhythm. For e.g.; HTN, DM, TB, HIV, Thyroid, Nephrotic disorders.
Known patients of malignancy, cervical erosion, polyp, endometriosis, tubo- ovarian mass and PCOS/PCOD.
Known case of structural anomalies of genital organs.
Patients using IUCD’s.
Post Ligation Syndrome Patients
Patients who recently undergone Dilatation and Curettage Surgery.
Patients undergoing treatment for any other serious illness.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of durva swaras bhavit jyotishmati vati in Artavkshaya with special reference to oligomenorrhea |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study detail about Artavkshaya
To study properties of durva swaras bhavit jyotishmati vati |
3 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Study is randomised open labelled clinical trail to assess an effect of durva swaras bhavit jyotishmati vati in Artavkshaya with special reference to oligomenorrhea Sample size is 90 There are two groups and each group has 45 samples Group A is trial and group B is control group Group A have durva swaras bhavit jyotishmati vati with Luke warm water 250mg BD for 90 days Group B have Rajapravartini vati with Luke warm water 250mg BD for 90 days Follow up on 30th day, 60th day, 90th day Analysis of data and interpretation of result
|